The Family Smoking Prevention and Tobacco Control Act requires the FDA to issue regulations that require color graphics depicting the health consequences of smoking on cigarette packages and in cigarette advertisements. As we previously reported here, on September 5, 2018, the U.S. District Court for the District of Massachusetts found that the FDA “unlawfully withheld” and “unreasonably delayed” the promulgation of a rule mandating color graphic warnings for cigarettes. The Court ordered the FDA to provide an accelerated timeline for the completion of its rulemaking. On October 5, 2018, the FDA provided the Court a proposed schedule that would result in the submission of the final rule for publication in the Federal Register by May 2021.

U.S. District Judge Indira Talwani recently rejected the FDA’s proposed schedule, asserting that, given the timeline originally set forth by Congress, the FDA’s proposed timeline and work completed thus far, the human health and welfare at stake, and the lack of competing priorities, the FDA failed to adequately justify its delay in promulgating a final rule. Accordingly, the Court ordered the FDA to issue a final rule mandating graphic health warnings on cigarette packs and advertising next year, by March 15, 2020. The Court also ordered that a proposed rule be submitted for publication in the Federal Register later this year, by August 15, 2019. The FDA was also ordered to complete the final qualitative study of nine graphic warnings and analysis earlier this month.

This decision makes the graphic health warning rule closer to becoming reality, and potentially adds the United States to the list of the 118 or so other countries that already require pictorial cigarette warnings. Depending on the content of the final warnings, it is reasonable to expect another legal challenge, which scuttled the FDA’s first effort at graphic health warnings.

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